Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Official Title: “Lamotrigine Extended-Release in Elderly Patients With Epilepsy”

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine
  • Open-label

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lamotrigine
  • Open-label lamotrigine

Primary Measures

• Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event
  • Time Frame: From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)
    Safety Issue?: Yes

Secondary Measures

• Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study
  • Time Frame: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)
    Safety Issue?: No
• Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study
  • Time Frame: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)
    Safety Issue?: No
• Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period
  • Time Frame: Week 30 or 33
    Safety Issue?: No
• Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale
  • Time Frame: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
    Safety Issue?: No
• Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale
  • Time Frame: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
    Safety Issue?: No
• Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
    Safety Issue?: No
• Change From Baseline in the Height at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
    Safety Issue?: No
• Change From Baseline in the Weight at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])
    Safety Issue?: No
• Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
  • Time Frame: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)
    Safety Issue?: No
• Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA
  • Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28
    Safety Issue?: No
• Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA
  • Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28
    Safety Issue?: No
• Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA
  • Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28
    Safety Issue?: No
• Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA
  • Time Frame: Weeks 4, 7, 11, 15, 20, 24, and 28
    Safety Issue?: No

Inclusion criteria:

• Confident diagnosis of epilepsy
• Currently treated with one or two antiepileptic medications
• Able to complete a seizure diary

Exclusion criteria:

• History of hypersensitivity to lamotrigine
• Progressive diseases that would interfere with the study objectives

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516139

Study ID Number: LEP105972

ClinicalTrials.gov Identifier: NCT00516139

Health Authority: United States: Food and Drug Administration